Generally, process control for the manufacturing or formulation of a product is important if not critical to providing a product of desired quality and/or that meets specifications. Deviation from the specified process can negatively affect quality, and in some situations can be dangerous. For some industries or products, deviation from specification may violate laws or regulations.
One industry in which specified product quality is often necessary is pharmaceutical manufacturing. Three main objectives typically govern the pharmaceutical manufacturing process. The first objective may be to maintain sterility of critical surfaces within the receiving chambers that contain the ingredient substances used in the manufacture and the manufactured formulations themselves. The second objective may be to maintain consistency and quality of the formulation being manufactured. Most formulations are a combination of different ingredients. These ingredients need to be blended in the most sustainable manner in order to ensure consistent quality of the resultant formulation for use by a patient. The third objective may be to avoid or limit particulate issues contaminating the ingredients as well as the formulation being manufactured. Traditional aseptic manufacturing involve a process by which sterile substances are transferred into sterile receiving chambers and the receiving chambers are closed after completion of filling—all within a classified environment.